Safety of Polyphenon E in Multiple Sclerosis Pilot Study

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00836719
• Date of registration: 03/02/2009
• Prospective Registration: No
• Primary sponsor: Louisiana State University Health Sciences Center in New Orleans
• Public title: Safety of Polyphenon E in Multiple Sclerosis Pilot Study
• Scientific title: Safety and Neuroprotective Effects of Polyphenon E in Multiple Sclerosis
• Date of first enrolment: February 2009
• Target sample size: 10
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00836719
• Study type: Interventional
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Jesus F Lovera, MD, MSPH
• Affiliation: LSUHSC

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of MS by McDonald criteria

- Relapsing-remitting MS or secondary progressive MS

- Stable therapy with Copaxone, for at least six months prior to inclusion in the study
or no therapy for six months in subjects refusing therapy.

- EDSS Score less than or equal to 6.5 (able to walk about 20 meters without resting)

- Ages 18-60.

- Leukocytes =3,000/µL

- Absolute neutrophil count =1,500/µL

- Platelets =100,000/µL

- Total bilirubin =local upper limit of normal

- normal AST (SGOT) ALT (SGPT)

- normal serum Creatinine

- women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry and for
the duration of study participation.

- Ability to understand and the willingness to sign a written informed consent document.

- Willing to drink at most one cup of black tea and two cups of coffee per day, and
abstain from drinking green tea or taking supplements containing green tea or green
tea compounds, for the duration of the investigation.

Exclusion Criteria:

- MS relapse within the 30 days prior to enrollment.

- A primary progressive form of MS.

- Previous treatment prior to study entry as follows: complete radiation ablation of the
bone marrow or anti-CD4 antibody treatment (Campath) at any time; mitoxantrone,
cyclophosphamide, cyclosporin, Natalizumab or other immunomodulatory or
immunosuppressant therapies except for Copaxone or methylprednisone for relapses
within prior nine months.

- History of renal or liver disease.

- Consumption of green tea or supplements containing green tea or tea extract within 30
days prior to enrollment.

- Participants may not participate in any other clinical trial involving investigational
agents during the study, or within six months prior to enrolling in the study.

- history of allergic reactions attributed to compounds of similar chemical or biologic
composition to Polyphenon E, tea, or any of the inactive ingredients present in the
active or placebo capsules, including gelatin.

- history of allergic reactions to gadolinium or any other condition contraindicated for
MRI.

- Uncontrolled, clinically-relevant active illness (aside from MS) including, but not
limited to, ongoing or active infection, symptomatic congestive heart failure,
unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations
that would limit compliance with study requirements.

- Any condition which would make the subject, in the opinion of the investigator,
unsuitable for the study.

- Inability to complete the baseline MRI scan.

- Pregnant or breastfeeding women.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Polyphenon E

Primary Outcome(s)

Number of Participants Experiencing Serious Adverse Events [Time Frame: six months]

Secondary Outcome(s)

Change in Brain NAA Level as Measured by MR Spectroscopy [Time Frame: 6 months]

Secondary ID(s)

1K23AT004433-01

K23AT004433-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Center for Complementary and Integrative Health (NCCIH)

Results

• Results available: Yes
• Date Posted: 27/06/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00836719